Overview

From 2001 to June 2011, the number of centers providing proton beam therapy grew from 3 to 10. From 2006 to 2009, the number of Medicare beneficiaries receiving proton beam therapy nearly doubled.

The near doubling of Medicare beneficiaries receiving proton beam therapy from 2006 to 2009 was due to a 68 percent increase in use for "conditions of possible benefit," mostly prostate cancer, with no increase in use for commonly accepted indications.

Prostate cancer is the most common condition for which a Medicare beneficiary recieves proton beam therapy.

CMS has yet to issue a national coverage rule for proton beam therapy or its specific indications.

Proton beam radiotherapy is a form of external beam radiation that offers better precision for localized dosage than other types of external beam radiotherapy. Because proton beams deposit most of their energy during the final portion of their trajectory, they diminish the risk of damage to tissue surrounding the tumor and thus allow for higher treatment doses with fewer side effects. Proton beam radiotherapy has been used in research applications since the 1950s and entered clinical practice in the United States in 1990.

No randomized controlled trials and only a few well-conducted cohort studies have compared proton beam radiation to other treatments. In the absence of evidence of clinical superiority, proton beam radiotherapy has gained acceptance based on a theoretical advantage for the treatment of specific cancers. Agreement is strongest for the use of proton radiotherapy for (1) tumors surrounded by critical structures such as the eye, brain, and spinal cord that preclude or complicate resection or other radiation techniques, or (2) tumors for which other treatments are not very effective. For example, proton beam radiotherapy is preferred for solid tumors in children because it minimizes detrimental effects of radiation on developing structures surrounding the tumor and reduces the risk of long-term side effects.

In January 2001, three proton beam treatment centers were operating in the United States (Loma Linda, California; Massachusetts General Hospital in Boston; and the University of California, San Francisco). By 2006, three additional centers had opened at Indiana University in Bloomington, M.D. Anderson Cancer Center in Houston, and the University of Florida in Gainesville, followed in 2009 by another in Oklahoma City. By June 2011, the United States was home to 10 proton beam treatment centers, with many more proposed or under construction

The number of proton beam centers also increased worldwide, from 17 centers operating outside of the United States in 2001 to 29 in 2011.

The Centers for Medicare & Medicaid Services (CMS) has yet to release a national coverage or noncoverage determination for proton beam radiotherapy, so local Medicare administrative contractors (previously known as fiscal intermediaries or carriers) have the authority to develop local coverage decisions (LCDs). Local advisory committees (with membership primarily comprising physicians) provide input for developing LCDs, which specify conditions for payment of claims, including acceptable procedure and diagnosis codes. The first LCDs for proton beam radiotherapy went into effect in 2009, prior to which LCDs included proton beam radiotherapy along with external beam radiotherapy in general but without identifying specific indications.

Currently, LCDs vary by contractor regarding their indications for coverage of proton beam radiotherapy, but most LCDs include one or more of the following:

A list of conditions for which proton beam radiotherapy is medically reasonable (e.g., eye, brain, and spinal cord) and a second list of conditions for which proton beam radiotherapy may be medically reasonable if specified requirements are met and documentation is adequate (e.g., lung, prostate).

A requirement that the medical record include evidence of benefit for proton beam radiotherapy over other treatment modalities.

A requirement (for some indications) that the patient be treated as part of a clinical trial.

Special documentation requirements for prostate cancer.

A statement that proton beam radiotherapy will be evaluated on a case-by-case basis. Providers must contact the contractor to discuss indications and payment.

Despite the rarity of commonly accepted indications such as tumors of the eye, skull base, and spinal cord, use of proton beam radiotherapy has accelerated in the last decade. Proponents argue that the theoretical advantages of the proton beam's precision apply to more common conditions such as prostate cancer and non-small cell lung cancer; however, no evidence exists for the comparative effectiveness or harms of this therapy. Financial factors may in part be driving this trend of including more common conditions among the indications for proton beam therapy, since expanding its use allows for faster recovery of the substantial investment needed to construct a proton beam center. A major concern among detractors of proton therapy is cost; one report cited costs of providing proton therapy that were more than double those of other radiation therapies. The difference in Medicare payment rates for proton beam radiotherapy versus other radiation therapies is not trivial.

Payment rates (which include both Medicare trust fund reimbursement and patient cost sharing) for proton beam radiotherapy vary by the type of facility providing the services and its location. Hospital-based treatment centers receive payments based on the Hospital Outpatient Prospective Payment System (HOPPS) ambulatory payment classifications (APCs), which are wage adjusted according to provider location. Rates for payments to freestanding centers are set by local Medicare administrative contractors based on Healthcare Common Procedure Coding System (HCPCS) codes. APC codes 664 and 667 and HCPCS codes 77520, 77522, 77523, and 77525 are used to bill for proton beam radiotherapy. Changes in payment for proton beam therapy between 2006 and 2009 varied across providers. Hospital outpatient-based facilities experienced a rate decrease from 2007 to 2009 followed by a return to 2007 levels in 2010 and 2011. Freestanding centers experienced variable changes. Some contractors reduced payment rates approximately 5 percent from 2008 to 2009, while others granted small increases (1 percent) in rates during the same period.

This report details the increased use of proton beam radiotherapy among Medicare beneficiaries from 2006 to 2009 in terms of both recipients and indications.